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Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)

31 augusti 2018 uppdaterad av: Washington D.C. Veterans Affairs Medical Center

Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration

This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This randomized controlled trial will have a sample size of 24. Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited. After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise. The intervention will occur weekly and last up to 2 hours. The control group will complete a 10week comprehensive health education program simultaneously. All measures will be collected again, post intervention. A follow-up collection will occur at 3 months post-intervention.

Studietyp

Interventionell

Inskrivning (Faktisk)

24

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20422
        • Washington DC VA medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • TBI of at least mild severity using criteria related to disturbance of consciousness
  • Most recent TBI occurred >1 year prior to consent process
  • Medically stable with physician approval to participate

Exclusion Criteria:

  • Unable to provide informed consent and no proxy available
  • Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
  • Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
  • Veteran is currently active in a skilled physical therapy program.
  • Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
Beteende: InFuSE
Each session includes a 45-minute education and group discussion. A 60-minute exercise component then completes the session. Each topic was specifically picked and tailored to benefit Veterans with TBI. The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities. The activities are included to help improve understanding and promote group discussion. The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
Aktiv komparator: Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
Beteende: Patient Education/Group Discussion
Each week you will participate in a 1 hour health education class with other Veterans. Each topic was specifically picked and tailored for Veterans with TBI. These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Exercise Self-Efficacy Scale (ESES)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Sleep Efficiency
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed. Sleep efficiency is measured by polysomnography.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Capacity
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test. The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Dynamic Gait Index (DGI)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Pittsburgh Sleep Quality Index (PSQI)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-reported measure to evaluate and monitor overall sleep quality.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Mayo Portland Adaptability Index (MPAI-4)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A measure of self-reported quality of life, limitation severity, and community participation after TBI.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Community Reintegration of Service Members (CRIS)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
California Verbal Learning Test-Second Edition (CVLT-II)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Brief Symptoms Inventory 18 (BSI-18)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-report measure of depression, anxiety, somatic concerns, and general distress.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Post-Traumatic Stress Disorder Checklist (PCL)
Tidsram: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington D.C. Veterans Affairs Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2016

Primärt slutförande (Förväntat)

1 december 2018

Avslutad studie (Förväntat)

1 december 2018

Studieregistreringsdatum

Först inskickad

28 mars 2017

Först inskickad som uppfyllde QC-kriterierna

17 maj 2017

Första postat (Faktisk)

19 maj 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 01798

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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